Trials / Completed
CompletedNCT00199771
Hypertonic Saline Dextran in Pediatric Cardiac Surgery
The Use of Hypertonic Saline Dextran in Cardiac Surgery Utilizing Cardio Pulmonary Bypass in Children Less Than 17 Weeks Old.
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 14 (planned)
- Sponsor
- Oslo University Hospital · Academic / Other
- Sex
- All
- Age
- 16 Weeks
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine whether infusion of hypertonic saline dextran attenuates the inflammatory response and the water overload, during and after major cardiac surgery in small children.
Detailed description
After major cardiac surgery in small children, extravasation of fluid due to increased capillary leak has negative effect on haemodynamics and respiration. Inflammation cascades are activated by surgery and the use of cardio pulmonary bypass (CPB). We want to test whether a small infusion of 7.5% NaCl in 6% dextran solution before and after CPB reduces inflammatory activation by measuring the levels of interleukins 6 and 8 (IL-6, IL-8). We also measure extravascular lung water, fluid balance and weight during the first 24 hours post CPB.
Conditions
- Heart Defects, Congenital
- Transposition of Great Vessels
- Heart Septal Defects, Ventricular
- Endocardial Cushion Defects
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 7.5% NaCl in 6% dextran 70 solution |
Timeline
- Start date
- 2003-06-01
- Primary completion
- 2004-12-01
- Completion
- 2005-02-01
- First posted
- 2005-09-20
- Last updated
- 2011-07-01
Source: ClinicalTrials.gov record NCT00199771. Inclusion in this directory is not an endorsement.